Bag CPAP vs Standard Oxygen Therapy in Acute Hypoxemic Respiratory Failure

Official title

Bag CPAP Versus Standard Oxygen Care for the Management of Acute Hypoxemic Respiratory Failure in Adults: A Randomized Controlled Trial

Overview

Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. The Bag CPAP may be useful in reducing the need for intubation and therefore mortality in patients with AHRF but data are lacking. This study aims to determine whether the Bag CPAP compared to standard oxygen care, could reduce the percentage of patients with criteria for intubation in patients with AHRF. This is a prospective randomized, open-label, controlled trial in which patients presenting at the emergency room in Rwanda will be randomly assigned to receive standard oxygen therapy or Bag CPAP. The primary endpoint is the percentage of patients with criteria for intubation at day 7. Secondary endpoints include the tolerance of the Bag CPAP, overall 28-day mortality rate, mortality rate of intubated patients on mechanical ventilation at day 28, percentage of patients intubated at 28 days, ventilator-free days at day 28, interval between the initiation of treatment and the onset of intubation criteria, the interval between the time when criteria for intubation are met and intubation, organ failure-free days at day 7 and length of hospital stay.

Interventions

• Device Bag CPAP
  Bag CPAP sessions in addition to standard oxygen therapy. The Bag CPAP will be delivered continuously for the first 6 to 12 hours, then for sessions of at least 4 hours per day.
• Device Standard oxygen
  Standard oxygen therapy via nasal prongs, simple facial masks, or non-rebreather masks, depending on the need, until endotracheal intubation, death, or the presence of oxygen therapy cessation criteria

Primary outcome measures

• Percentage of patients with criteria for intubation at day 7 [Time frame: Day-7]

Secondary outcome measures (7)

• Tolerance of the Bag CPAP [Time frame: up to day-28]
• Mortality rate of intubated patients on mechanical ventilation [Time frame: Up to day-28]
• Ventilator-free days [Time frame: up to day-28]
• Organ failure-free days [Time frame: Day-7]
• Mortality rate [Time frame: Up to day-28]
• Duration of hospital stay [Time frame: Up to day-28]
• Percentage of patients intubated [Time frame: Day-28]

Eligibility criteria

• Inclusion criteria

All patients aged 18 years or older will be included in the study if they meet the following criteria:

• De novo acute respiratory distress, characterized by the presence of dyspnea at rest, the use of accessory muscles for breathing, or a respiratory rate of 25 cycles per minute or more.
• Hypoxemia, defined as a SpO2/FiO2 ratio less than 315 or a PaO2/FiO2 ratio less than 300 mmHg (if arterial blood gas is available) despite an oxygen therapy of 6 L/min. FiO2 will be estimated by the rule of 3% (Coudroy formula)(18,22). SpO2 should be less than 98% when assessing the SpO2/FiO2 ratio.
• Exclusion criteria

Patients with one of the following criteria will be excluded from the study:

• Absolute contraindications to CPAP: patient's refusal, uncontrollable vomiting, upper gastrointestinal bleeding, open or sucking chest wound, pneumothorax not drained, craniofacial trauma, severe burns to the face, severe upper airway obstruction, traumatic tetraplegia at the initial stage, tracheostomy.
• Moderate to massive pleural effusion not drained
• Cardiac arrest, severe ventricular arrhythmias, and shock defined as the need for vasopressor support (adrenaline, noradrenaline, or dopamine)
• Altered level of consciousness (GCS below 12), repetitive convulsions, or status epilepticus
• Do not intubate or resuscitate order before the inclusion in the study
• Refusal to participate, already included in the study, enrollment in another interventional trial on acute respiratory failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Rwanda · 1 center

• University of Rwanda — Kigali

Publications

• de Beaufort E, Carteaux G, Morin F, Lesimple A, Haudebourg AF, Fresnel E, Duval D, Broc A, Mercat A, Brochard L, Savary D, Beloncle F, Mekontso Dessap A, Richard JC. A new reservoir-based CPAP with low oxygen consumption: the Bag-CPAP. Crit Care. 2023 Jul 4;27(1):262. doi: 10.1186/s13054-023-04542-2. PMID 37403149
• Kwizera A, Nakibuuka J, Nakiyingi L, Sendagire C, Tumukunde J, Katabira C, Ssenyonga R, Kiwanuka N, Kateete DP, Joloba M, Kabatoro D, Atwine D, Summers C. Acute hypoxaemic respiratory failure in a low-income country: a prospective observational study of hospital prevalence and mortality. BMJ Open Respir Res. 2020 Nov;7(1):e000719. doi: 10.1136/bmjresp-2020-000719. PMID 33148779
• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. d PMID 26903337

Identifiers

NCT: NCT07460427 · URICU250

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗